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Completed

NCT Number: NCT03528863

Web-based Mindfulness Meditation in Reducing Distress in Participants With Metastatic Gastrointestinal Cancer and Their Caregivers

This trial studies how well web-based mindfulness meditation works in reducing distress in both participants with gastrointestinal cancer that has spread to other parts of the body, and their caregivers. Web-based mindfulness meditation, which uses audio exercises and interactive webinars taught by trained meditation instructors, may help participants with GI cancer and their caregivers reduce distress and improve their quality of life.

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Key information

Conditions

Caregiver Metastatic Gastrointestinal Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94115, United States

About this study

PRIMARY OBJECTIVES:

I. To determine the feasibility and acceptability of an 8-week web-based mindfulness meditation program with live webinars among patients with a metastatic gastrointestinal (GI) cancer receiving chemotherapy and their caregivers.

SECONDARY OBJECTIVES:

I. Estimate the efficacy of an 8-week web-based mindfulness meditation program with live webinars among patients with a metastatic GI cancer receiving chemotherapy and their caregivers.

OUTLINE:

Participants practice with web-based mindfulness meditation over 10-15 minute guided audio sessions for 5 days a week for 8 weeks. Participants also attend meditation webinars over 60 minutes once a week, for 8 weeks.

After completion of study, participants are followed up at 8 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ELIGIBLE PATIENTS: Carry a diagnosis of a metastatic GI cancer
  • ELIGIBLE PATIENTS: Anticipate receiving chemotherapy for at least 12 weeks total from the time of recruitment
  • ELIGIBLE PATIENTS: Have an estimated life expectancy of at least 6 months, assessed by principal investigator or treating investigator
  • ELIGIBLE PATIENTS: Have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2
  • ELIGIBLE PATIENTS: Be able to speak and read English
  • ELIGIBLE PATIENTS: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
  • ELIGIBLE PATIENTS: Have daily access to a mobile phone capable of receiving text messages, as determined by a study investigator
  • ELIGIBLE PATIENTS: Be able to provide informed consent
  • ELIGIBLE CAREGIVERS: Be a spouse/partner, other family member, or a close friend of a patient who consented to participate in the Being Present 2.0 study
  • ELIGIBLE CAREGIVERS: Be able to speak and read English
  • ELIGIBLE CAREGIVERS: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
  • ELIGIBLE CAREGIVERS: Have access to a mobile phone capable of receiving text messages, as determined by a study investigator
  • ELIGIBLE CAREGIVERS: Be able to provide informed consent

Exclusion criteria

  • Have a current meditation practice (> 2 episodes or > 1 hour total, weekly)
  • Be currently enrolled in a stress reduction program
  • Have extensive hearing loss such that ability to participate in the study would be impaired
  • Have participated in the original Being Present pilot study (BP1)
  • Be caregivers of patients who decline Being Present 2.0 (BP2) study participation

Treatment and study plan

Online Mindfulness Meditation

Behavioral

Receive web-based mindfulness meditation

Other names: Online Mindful Meditation; Online Mindfulness-Based Stress Reduction (MBSR); Online Mindfulness Relaxation; Online MBSR; Web-Based Mindfulness Meditation

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Feasibility as assessed by evaluating recruitment rate

    Time frame: At end of enrollment (Up to 1 year)

    Number of participants approached who consent to participate

  2. Feasibility as assessed by evaluating rate of refusal to participate

    Time frame: At end of enrollment (Up to 1 year)

    Number of participants refusing to consent.

  3. Feasibility as assessed by rate of attrition

    Time frame: At 8 weeks post end of enrollment (Up to 1 year)

    Number of participants dropping out after start of intervention for any reason.

  4. Acceptability as assessed by adherence to practice instructions

    Time frame: At 8 weeks after study start (Up to 1 year)

    Number of times participant practices during study, documented via website data capture

  5. Acceptability as assessed by adherence to practice instructions

    Time frame: At 8 weeks after study start (Up to 1 year)

    Number of times participant watches recorded webinars, documented via website data capture

  6. Acceptability as assessed by adherence to practice instructions

    Time frame: At 8 weeks after study start (Up to 1 year)

    Number of times patient participates in live webinars, documented via roll-call.

  7. Acceptability as assessed by adherence to practice instructions

    Time frame: At 8 weeks after study start (Up to 1 year)

    Average duration of meditation session (measured in minutes), documented via website data capture.

Secondary outcomes

  1. Efficacy as assessed by National Comprehensive Cancer Network (NCCN) Distress Thermometer

    Time frame: At baseline, week 4 and week 8 after study start (Up to 1 year)

    0 to 10, with 10 being the worst level of distress

  2. Efficacy as assessed by National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS)

    Time frame: At baseline, week 4 and week 8 after study start (Up to 1 year)

  3. Efficacy as assessed by a Five Facet Mindfulness Questionnaire Short (FFMQ-SF)

    Time frame: At baseline, week 4 and week 8 after study start (Up to 1 year)

  4. Efficacy as assessed by a "Are You at Peace?" one-item spiritual probe

    Time frame: At baseline, week 4 and week 8 after study start (Up to 1 year)

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

Being Present 2.0: Web-Based Mindfulness Meditation for Gastrointestinal Cancer Patients and Caregivers

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 18, 2018
Registry last updated
Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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